text:
Participating Organization(s) |
U.S Food and Drug Administration (FDA) The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process. |
Office of Orphan Products Development (OPD) (http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm) |
Funding Opportunity Title |
Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
Reissue of RFA-FD-11-001 |
Related Notices |
Funding Opportunity Announcement (FOA) Number |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.103 |
Funding Opportunity Purpose |
The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a rare disease or condition and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. |
Posted Date |
August 1, 2012 |
Open Date (Earliest Submission Date) |
December 10, 2012 |
Letter of Intent Due Date |
Not Applicable. |
Application Due Date(s) |
Due Date(s): February 6, 2013; February 5, 2014 by
5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable. |
Scientific Merit Review (Peer Review) |
Advisory Council Review |
September 2013 and 2014 and February 2014 and 2015 |
Earliest Start Date(s) |
Expiration Date |
February 6, 2014, October 16, 2014 resubmission |
Due Dates for E.O. 12372 |
Not Applicable. |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Part 1.
Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
Section III. Eligibility Information
1. Eligible Applicants
Cost Sharing or Matching
3. Additional
Information on Eligibility
Section IV. Application and Submission
1. Requesting an Application Package
Content and Form of Application Submission
Submission Dates and Times
Intergovernmental Review
Funding Restrictions
Other Submission Requirements and Information
Section V. Application Review Information
1. General
2. Scientific
/Technical Review Criteria
3. Program Review Criteria
4. Additional Review Criteria
5. Additional Review Considerations
6. Review and Selection Process
7. Anticipated Announcement and Award Dates
Section VI. Award Administration
1. Award Notices
Administrative and National Policy Requirements
Section VII. Agency Contacts
1. Application Submission Contacts
2. Scientific/Research Contact(s)
Financial/Grants Management Contact(s)
Section VIII. Other Information
1. Required Federal Citations
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The OPD was created to identify and promote the development of orphan products.
Orphan products are drugs, biologics, medical devices, and medical foods that
are indicated for a rare disease or condition. The term rare disease or
condition is defined in 21 U.S.C. 360ee. As a practical way to implement the
statutory definition, for devices and foods as well as for drugs, FDA considers
drugs, devices, and medical foods potentially eligible for grants under the OPD
grant program if they are indicated for a disease or condition that has a prevalence,
not incidence, of fewer than 200,000 people in the United States. Diagnostics
and vaccines are considered potentially eligible for such grants only if the U.S. population to whom they will be administered is fewer than 200,000 people in the United States per year.
Research Objectives
The goal of FDA's OPD grant program is to support the
clinical development of products for use in rare diseases or conditions where
no current therapy exists or where the proposed product will be superior to the
existing therapy. FDA provides grants for clinical studies on safety and/or
effectiveness that will either result in, or substantially contribute to,
market approval of these products. Applicants must include in the application's
Background and Significance section documentation to support that
the estimated prevalence of the orphan disease or condition in the
United States is less than 200,000 (or in the case of a vaccine or
diagnostic, information to support that the product will be administered to
fewer than 200,000 people in the United States per year),and an explanation
of how the proposed study will either help support product approval or provide
essential data needed for product development. Additional information may
be required upon request, for example, regarding population estimate and
rationale. This additional information may be required, in part, to
assure that human clinical trials of drugs are eligible to receive funding
under the OPD grant program. 21 U.S.C. 360ee(b)(1)(A).See Section VIII, Other Information - Required
Federal Citations, for policies related to this announcement.
Section II. Award Information
Grant |
Application Types Allowed |
New Note about Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the most recent peer review critique (Summary Statement). Summary Statements must be included as an appendix in the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
Office of Orphan Products Development intends to commit $14.1 million in FY 2014 and FY2015. Of the estimated FY 2014 funding ($14.1 million), approximately $10 million will fund non-competing continuation awards, and approximately $4.1 million will fund 5 to 10 new awards, subject to availability of funds. It is anticipated that funding for the number of non-competing continuation awards and new awards in FY 2015 will be similar to FY 2014. |
Award Budget |
Phase 1 studies are eligible for grants of up to $200,000 per year for up to 3 years. Phase 2 and 3 studies are eligible for grants of up to $400,000 per year for up to 4 years. Please note that the dollar limitation will apply to total costs (direct plus indirect). Budgets for each year of requested support may not exceed the $200,000 or $400,000 total cost limit, whichever is applicable. The following definitions are provided to illustrate drug and biologic products study phases. Devices and medical foods may have alternative considerations. Phase 1 studies include the initial introduction of an investigational new drug (IND) into humans, are usually conducted in healthy volunteer subjects, and are designed to determine the metabolic and pharmacological actions of the product in humans, and the side effects, including those associated with increasing drug doses. In some Phase 1 studies that include subjects with the rare disorder, it may also be possible to gain early evidence on effectiveness. Phase 2 studies include early controlled clinical studies conducted to: (1) Evaluate the effectiveness of the product for a particular indication in patients with the disease or condition and (2) determine the common short-term side effects and risks associated with it. Phase 3 studies gather more information about effectiveness and safety that is necessary to evaluate the overall risk-benefit ratio of the product and to provide an acceptable basis for product labeling. |
Award Project Period |
The length of support will depend on the nature of the study. For those studies with an expected duration of more than 1 year, a second, third, or fourth year of noncompetitive continuation of support will depend on the following factors: (1) Performance during the preceding year; (2) compliance with regulatory requirements of IND/investigational device exemption (IDE), if applicable; and (3) availability of Federal funds. In addition to the requirement for an active IND/IDE discussed in Section V.3 of this document, documentation of assurances with the Office of Human Research Protection (OHRP) (see Section IV.5.A of this document) must be on file with the FDA grants management office before an award is made. Any institution receiving Federal funds must have an institutional review board (IRB) of record even if that institution is overseeing research conducted at other performance sites. To avoid funding studies that may not receive or may experience a delay in receiving IRB approval, documentation of IRB approval and Federal Wide Assurance (FWA or assurance) for the IRB of record for all performance sites must be on file with the FDA grants management office before an award to fund the study will be made. In addition, if a grant is awarded, grantees will be informed of any additional documentation that should be submitted to FDA's IRB. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the FDA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. FDA grants policies as described in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the applications submitted and awards made in response to this FOA. |
FDA grants policies as described in the FDA Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations
The following
organizations/institutions are eligible to apply:
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards.
(non-U.S.) Entities (Foreign Institutions) are eligible to apply.
organizations must complete the following registrations as described in the SF
424 (R&R) Application Guide to be eligible to apply for or receive an
award. Applicants must have a valid Dun and Bradstreet Universal Numbering
System (DUNS) number in order to begin each of the following registrations.
Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with
their institutional officials to register with the eRA Commons or ensure their
existing eRA Commons account is affiliated with the eRA Commons account of the
applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.
Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry
out the proposed research as the PD/PI is invited to work with his/her
organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for support.
The Project
Director/Principal Investigator (PD/PI) will be solely
responsible for planning, directing, and executing the proposed project.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
Multiple PDs/PIs
The decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs grant is the responsibility of the investigators and applicant
organizations and should be determined by the scientific goals of the project.
Applications for grants with multiple PDs/PIs will require additional
information, as outlined in the instructions below. More than one PD/PI (i.e.,
multiple PDs/PIs), may be designated on the application for projects that
require a team science approach and therefore clearly do not fit the
single-PD/PI model. Additional information on the
implementation plans and policies and procedures to formally allow more than
one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi.
When multiple PDs/PIs are proposed, FDA requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the FDA, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected. All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI
Leadership Plan
For applications designating multiple PDs/PIs, a new section of the research
plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan
Component in the SF424 (R&R)], must be included. A rationale for choosing a
multiple PD/PI approach should be described. The governance and
organizational structure of the leadership team and the research project should
be described, and should include communication plans, process for making
decisions on scientific direction, and procedures for resolving
conflicts. The roles and administrative, technical, and scientific
responsibilities for the project or program should be delineated for the
PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Applications Involving a Single Institution
all PDs/PIs are within a single institution, follow the instructions contained
in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are
involved, one institution must be designated as the prime institution and
funding for the other institution(s) must be requested via a subcontract to be
administered by the prime institution. When submitting a detailed budget, the
prime institution should submit its budget using the Research & Related
Budget component. All other institutions should have their individual
budgets attached separately to the Research & Related Subaward Budget
Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application
Guide for further instruction regarding the use of the subaward budget
2. Cost Sharing or Matching
This grant program does not
require cost sharing as defined in the HHS Grants
Policy Statement.
3. Additional Information on
Number of Applications
organizations may submit more than one application, provided each application
is scientifically distinct.
FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.
Section IV. Application and Submission Information
To comply with the President's Management Agenda, HHS is participating as a partner in the new government-wide grants.gov application site. Applicants should apply electronically by visiting the web site www.grants.gov and following instructions under Apply for Grants. Users of grants.gov will be able to download a copy of the application package, complete it offline, and then upload and submit the application via the grants.gov web site. We strongly encourage using the Tips posted on www.grants.gov under the announcement number when preparing your submission. This process is similar to the R01 Grant Application process currently used at the National Institutes of Health (NIH). You can visit the following website for helpful background on preparing to apply, preparing an application, and submitting an application to Grants.gov: http://era.nih.gov/ElectronicReceipt/. In order to apply electronically, the applicant must have a Data Universal Number System (DUNS) number, and register in the Central Contractor Registration (CCR) database, in eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm), and in grants.gov (further information below).
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that web site.
A one-time registration is required for institutions/organizations at both:
A registration process with Grants.gov and eRA Commons is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons (https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp)
3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the eRA Commons System (COM) Users Guide.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons (https://commons.era.nih.gov/commons/). The FDA will accept electronic applications only from organizations that have completed all necessary registrations.
If you experience technical difficulties with your online submission, you should contact the grants.gov Customer Response Center http://www.grants.gov/contactus/contactus.jsp. If the Customer Response Center is unable to resolve your problem, please contact Vieda Hubbard, Grants Management Specialist, Division of Acquisition Support and Grants (DASG), Office of Acquisition and Grant Services (OAGS), Food and Drug Administration, at 301-827-7177, or by e-mail at email@example.com.
1. Requesting an
Application Package
must download the SF424 (R&R) application package associated with this
funding opportunity using the Apply for Grant Electronically button in this
FOA or following the directions provided at Grants.gov.
In FY 2014 and 2015, all applications must be submitted electronically through Grants.gov. Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through http://www.grants.gov/applicants/apply_for_grants.jsp.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA). Please locate the
current package each cycle to obtain the most up to date forms to download and
submit. Forms may change between receipt dates.
For further assistance, contact: Vieda Hubbard at 301-827-7177.
Telecommunications for the hearing impaired: 301-480-0434.
2. Content and Form of Application
is critical that applicants follow the instructions in the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through http://www.grants.gov/applicants/apply_for_grants.jsp.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to FDA. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by FDA (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications (http://grants.nih.gov/grants/ElectronicReceipt/faq_full.htm#application).
Special instructions for applicants who are submitting a
renewal or revision
Applicants submitting a renewal or resubmission are
required to enter the previous grant number into the Federal Identifier field
in the SF424 (R&R) Cover Component form (box #8). Renewal and
resubmission applications that do not include this number will receive an error
message. Applicants should log on to the eRA Commons to obtain the
previous grant number. If the number is not available in Commons, contact Vieda
Hubbard, 301- 827-7177 at FDA to get the previous grant number in order to
submit the application. Visit http://era.nih.gov/ElectronicReceipt/resubmission_FAQ.htm for additional information. If an application for the same study was
submitted in response to a previous request for application (RFA) but has not
yet been funded, an application in response to this notice will be considered a
request to withdraw the previous application. The applicant for a resubmitted
application should address the issues presented in the summary statement from
the previous review and include a copy of the summary statement itself as part
of the resubmitted application. A resubmission application should be
complete and stand alone from previous versions. An application that has
received two prior disapprovals is not eligible for resubmission.
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through http://www.grants.gov/applicants/apply_for_grants.jsp. Please locate the current package each cycle to obtain the most up-to-date forms to download and submit. Forms may change between receipt dates.
Note that the move to electronic applications has brought a change in terminology. The Grants.gov terminology is as follows:
New = New
Resubmission = A Revised or Amended application
Renewal = Competing Continuation
Continuation = Noncompeting Progress Report
Revision = Competing Supplement
The forms package associated with this FOA includes all applicable components, mandatory and optional. The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in http://www.grants.gov/applicants/apply_for_grants.jsp includes all applicable components, required and optional. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Research & Related Budget
Research & Related Subaward Budget Attachment(s) Form
Optional Components:
PHS398 Cover Letter File
Foreign Organizations (Non-domestic (non-U.S.) Entity)
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
See Section III.1.B
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
See the following for page instructions: http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/WhomtoContactaboutOrphanProductDevelopment/ucm186346.htm
PHS 398 Research Plan Component
All instructions in the SF424
(R&R) Application Guide must be followed, with the following additional
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide unless otherwise stated per FDA's guidelines located at http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/WhomtoContactaboutOrphanProductDevelopment/ucm186346.htm. Although each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to FDA in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Sharing Plans
Applicants must follow the specific instructions
on Appendix materials as described in the SF424 (R&R) Application Guide
(See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Foreign Institutions3. Submission Dates and Times
Part I. Overview Information contains information
about Key Dates. Applicants are encouraged to submit in advance of the deadline
to ensure they have time to make any application corrections that might be
necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
See Section IV.3.A. for details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: December
6, 2013 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable.
Application Due Date(s): February 6, 2013 and February 5,
Due Date(s): October 15, 2013 and October 15, 2014
Peer Review Date(s): May 2013 and 2014 and November 2013 and
Council Review Date(s): September 2013 and 2014 and
February 2014 and 2015
Earliest Anticipated Start Date(s): November
2013 and November 2014
Please note that there is only one receipt date for FY 2014 and one receipt date for FY 2015 for new and resubmitted applications. Resubmissions and applications that were submitted previously will be allowed to resubmit October 15, 2013 and October 15, 2014. Resubmissions will also be accepted in the February receipt dates in both Fiscal years.
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). Applications must be received by the close of business on the established receipt date. Late applications may be accepted under extreme circumstances beyond the control of the applicant. Applications not received on time will not be considered for review and will generally be returned to the applicant.
The protocol in the grant application should be submitted to the IND/IDE no later than January 7, 2013 for FY 2014 and no later than January 6, 2014 for FY 2015. The current version of the protocol that is included in the grant application and is intended to be used if the study is funded is the protocol that MUST be submitted to the IND/IDE before the application is reviewed. The date that corresponds with the IND/IDE submission/amendment date that corresponds to the protocol in the grant application should be reported in the title of the grant with the IND/IDE number. For resubmissions, if any changes to the protocol have occurred since the last review, the protocol must be resubmitted as an amendment to the IND/IDE prior to the October resubmission dates.
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the FDA
To submit an application in response to this FOA,
applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the FDA Referral Office by email email@example.com when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00
p.m. local time (of the applicant
institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due
date(s) and time, the application may be delayed in the review process or not
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday- Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for
completeness. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov
and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed. However, the FDA will accept a resubmission application, but such application must include an Introduction (1 page maximum) addressing the critique from the previous review.
4. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental
5. Funding
All FDA awards are subject to the terms
and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
The requirement to file an assurance applies to both awardee and collaborating performance site institutions. Awardee institutions are automatically considered to be engaged in human subject research whenever they receive a direct HHS award to support such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the awardee institution bears the responsibility for protecting human subjects under the award.
The awardee institution is also responsible for, among other things, ensuring that all collaborating performance site institutions engaged in the research hold an approved assurance prior to their initiation of the research. No awardee or performance site institution may spend funds on human subject research or enroll subjects without the approved and applicable assurance(s) on file with OHRP. An awardee institution must, therefore, have its own IRB of record and assurance. The IRB of record may be an IRB already being used by one of the performance sites, but it must specifically be registered as the IRB of record with OHRP.
For further information, applicants should review the section on human subjects in the application instructions as posted on the Grants.gov application Web site. The clinical protocol should comply with ICHE6 Good Clinical Practice Consolidated Guidance which sets an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. All human subject research regulated by FDA is also subject to FDA's regulations regarding the protection of human subjects (21 CFR parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and good clinical practice available on the Internet at http://www.fda.gov/oc/gcp/.
Key Personnel and Human Subject Protection Education
The awardee institution is responsible for ensuring that all key personnel
receive appropriate training in their human subject protection responsibilities.
Key personnel include all principal investigators, co-investigators, and
performance site investigators responsible for the design and conduct of the
study. HHS, FDA, and OPD do not prescribe or endorse any specific education
programs. Many institutions have already developed educational programs on the
protection of research subjects and have made participation in such programs a
requirement for their investigators. Other sources of appropriate instruction
might include the online tutorials offered by the Office of Human Subjects
Research, NIH at http://ohsr.od.nih.gov/ and by OHRP at http://www.hhs.gov/ohrp/education/.
Within 30 days of the award, the principal investigator should provide a letter to FDA's grants management office that includes the names of the key personnel, the title of the human subjects protection education program completed for each key personnel, and a one-sentence description of the program. This letter should be signed by the principal investigator and cosigned by an institution official and sent to the Grants Management Specialist whose name appears on the official Notice of Grant Award (NGA).
6. Other Submission Requirements and
must be submitted electronically following the instructions described in the SF
424 (R&R) Application Guide. Paper
applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to FDA.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization's profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications
will be evaluated for completeness. Applications that are incomplete will
not be reviewed.
6.A. Informed Consent
Consent forms, assent forms, and any other information given to a subject are
part of the grant application and must be provided, even if in a
draft form. The consent forms should be attached in an appendix section. The
applicant is referred to HHS and FDA regulations at 45 CFR 46.116 and 21 CFR
50.25 for details regarding the required elements of informed consent.
6.B. PD/PI Credential (e.g.,
Agency Login)
FDA requires the PD/PI(s) to fill in his/her Commons User ID in the PROFILE
Project Director/Principal Investigator section, Credential log-in field of the
Research & Related Senior/Key Person Profile component.
6.C. Organizational DUNS
The applicant organization must include its DUNS number in
its Organization Profile in the eRA Commons. This DUNS number must match the
DUNS number provided at CCR registration with Grants.gov. For additional
information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant
Section V. Application Review Information
1. General Information
grants management and program staff will review all applications sent in
response to this notice. To be responsive, an application must be submitted in
accordance with the requirements of this notice. Applications found to be
non-responsive will receive notice that the application will not be reviewed.
Applicants are strongly encouraged to contact FDA to resolve any questions about criteria before submitting their application. Please direct all questions of a technical or scientific nature to the OPD program staff and all questions of an administrative or financial nature to the grants management staff (see Agency Contacts in Section VII of this document).
Responsive applications will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts in the subject field of the specific application. Consultation with the proper FDA review division may also occur during this phase of the review to determine whether the proposed study will provide acceptable data that could contribute to product approval. Responsive applications may be subject to a second review by the National Cancer Institute, National Cancer Advisory Board (NCAB) for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of Food and Drugs or his designee. By submitting an application in response to this RFA, applicants understand and agree that members of the ad hoc panel of experts and the NCAB may be provided access to non-public information contained in the grant application, as necessary for evaluation of the application and subject to necessary restrictions on the further disclosure of the information.
A score will be assigned to each application based on the scientific/technical review criteria. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the OPD grant program.
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product will be superior to the existing therapy. In their written critiques, reviewers will be asked to comment on each of the following criteria in addition to the Scientific/Technical Review Criteria outlined below, in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score.
Investigators: Assessing the competence of the principal investigator(s) and key personnel to conduct the proposed research. This includes their academic qualifications, research experiences, productivity, and any special attributes.
Resources and Environment: Evaluating any special attributes or deficiencies relevant to the conduct of the proposed studies.
Budget: Evaluating whether all items of the requested budget are appropriate and justified.
Human Subjects and Monitoring: Evaluating possible physical, psychological, or social injury patients might experience as subjects in the proposed research. Discussing whether the rights and welfare of the individuals will be adequately protected. Assessing the safety-monitoring plan including the reporting of adverse events. Evaluating the informed consent documents as well as the plan to monitor the integrity of the data collected and the compliance with the protocol.
2. Scientific/Technical Review Criteria1. The soundness of the rationale for the proposed study;
2. The quality and appropriateness of the study design, including the design of the monitoring plans;
3. The statistical justification for the number of patients chosen for the study, based on the proposed outcome measures, and the appropriateness of the statistical procedures for analysis of the results;
4. The adequacy of the evidence that the proposed number of eligible subjects can be recruited in the requested timeframe;
5. The qualifications of the investigator and support staff, and the resources available to them;
6. The adequacy of the justification for the request for financial support;
7. The adequacy of plans for complying with regulations for protection of human subjects and monitoring; and
8. The ability of the applicant to complete the proposed study within its budget and within time limits stated in this FOA.
3. Program Review Criteria2. There must be an explanation in the Background and Significance section of how the proposed study will either contribute to product approval or provide essential data needed for product development.
3. The Background and Significance section of the application must contain information documenting that the disease or condition to be treated meets the definition of a rare disease or condition, as defined in 21 U.S.C. 360ee. FDA generally considers drugs, devices, and medical foods potentially eligible for grants under the OPD grant program if they are indicated for a disease or condition that has a prevalence, not incidence, of fewer than 200,000 people in the United States. Diagnostics and vaccines are considered potentially eligible for such grants only if the U.S. population to whom they will be administered is fewer than 200,000 people in the United States per year.
4. With the exception noted below, the study protocol proposed in the grant application must be under an active IND or IDE (not on clinical hold) to qualify the application for scientific and technical review. Additional IND/IDE information is described as follows:
The proposed clinical protocol should be submitted to the applicable FDA IND/IDE review division a minimum of 30 days before the grant application deadline. The number assigned to the IND/IDE that includes the proposed study should appear on the face page of the application with the title of the project. The date the subject protocol was submitted to FDA for the IND/IDE review should also be provided. Protocols that would otherwise be eligible for an exemption from the IND regulations must be conducted under an active IND to be eligible for funding under this FDA grant program. If the sponsor of the IND/IDE is other than the principal investigator listed on the application, a letter from the sponsor permitting access to the IND/IDE must be submitted in both the IND/IDE and in the grant application. The name(s) of the principal investigator(s) named in the application and in the study protocol must be submitted to the IND/ IDE. Studies of already approved products, evaluating new orphan indications, are also subject to these IND/IDE requirements.
Only medical foods that do not need pre-market approval and medical devices that are classified as non-significant risk (NSR) are free from these IND/IDE requirements. Applicants studying an NSR device should provide a letter in the application from the FDA Center for Devices and Radiologic Health indicating the device is an NSR device.
5. The requested budget must be within the limits, either $200,000 in total costs per year for up to 3 years for any phase study, or $400,000 in total costs per year for up to 4 years for Phase 2 or 3 studies. Any application received that requests support over the maximum amount allowable for that particular study will be considered non-responsive.
6. In an appendix to the application, there must be evidence that the product to be studied is available to the applicant in the form and quantity needed for the clinical trial proposed. A current letter from the supplier as an appendix will be acceptable. If negotiations regarding the supply of the study product are underway but have not been finalized at the time of application, please provide a letter indicating such in the application. Verification of adequate supply of study product will be necessary before an award is made.
7. The protocol should be submitted in the application. The protocol may be included as an appendix. Page limits, font size and margins should comply with the Application Guide, Electronic Submission of Grant Applications (http://era.nih.gov/ElectronicReceipt/faq_prepare_app.htm#1).
8. Additional information may be required upon request, for example, regarding population estimate and rationale. This additional information may be required, in part, to assure that human clinical trials of drugs are eligible to receive funding under the OPD grant program. 21 U.S.C. 360ee(b)(1)(A).
4. Additional Review Criteria
applicable for the project proposed, reviewers will evaluate the following
additional items while determining scientific and technical merit, and in
providing an overall impact/priority score, but will not give separate scores
for these items.
Protection of Human Subjects
For research that involves human subjects but does not
involve one of the six categories of research that are exempt under 45 CFR Part
46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the
criteria for one or more of the six categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials. For additional information on review of the Human Subjects section,
please refer to the Human Subjects Protection and Inclusion Guidelines. See the
Human Subjects Sections of the PHS398 Research Plan component of the SF424
Inclusion of Women, Minorities and Children in Research
The committee will evaluate the proposed plans
for inclusion of minorities
and members of both genders, as well as the inclusion of children as
appropriate for the scientific goals of the research will be assessed. Plans
for the recruitment and retention of subjects will also be evaluated. See the
Human Subjects Sections of the PHS398 Research Plan component of the SF424
(R &R). For
additional information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.
Reviewers will assess whether materials or procedures proposed are potentially
hazardous to research personnel and/or the environment, and if needed,
determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now
presented, taking into consideration the responses to comments from the
previous scientific review group and changes made to the project. The adequacy
of the responses to comments from the most recent scientific review group will
be assessed including the appropriateness of the improvements in the
resubmission application.
Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). The Summary Statement must be included as an Appendix in the application.
Resubmissions are intended for those applications that were previously submitted to OPD, reviewed and received a score on the application.
Renewal applications will be permitted for this FOA. For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Active grants in regulatory compliance may be eligible to submit a competing supplement application. A competing supplement (also called Revision) is a request for additional funds for a current award to expand the scope of work. Competing supplements may be submitted throughout the fiscal year and will be permitted for this FOA to compete for funding. Please contact the OPD program contact for further information.
Additional Review Considerations
applicable for the project proposed, reviewers will consider each of the
following items, but will not give scores for these items, and should not
consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions in other
countries that are not readily available in the United States or that augment
existing U.S. resources.
Resource Sharing Plans
Budget and Period of Support
will consider whether the budget and the requested period of support are fully
justified and reasonable in relation to the proposed research. The
priority score should not be affected by the evaluation of the budget.
Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
7. Anticipated Announcement and Award
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.
Earliest Anticipated Start/Award Date(s): November
1, 2013 and November 1, 2014
Section VI. Award Administration
1. Award Notices
If the application is under consideration for funding, FDA
may request information from the applicant prior to making the award. For
details, applicants may refer to the HHS Grants
Policy Statement.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
must comply with any funding restrictions described in Section
IV.5. Funding Restrictions. Selection of
an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award
costs. See Section IV.5., Funding Restrictions.
the review of the application is completed, the PD/PI will be able to access
his or her Summary Statement (written critique) via the eRA Commons.
2. Administrative and National Policy Requirements
All FDA grant and cooperative agreement awards include
the HHS Grants Policy Statement as part of the NoA. For these terms of
award, see the HHS Grants
Policy Statement.
3. Reporting
multiple years are involved, awardees will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the HHS Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.
3.A. Monitoring Activities
The guidelines
below are intended to provide information for principal investigators who are
conducting clinical trials. The procedures outlined herein are in addition to
(and not in lieu of) Institutional Review Board (IRB), Office for Human
Research Protections (OHRP), other Food and Drug Administration (FDA), and Good
Clinical Practices requirements.
It is an OPD policy that data and safety monitoring of a clinical trial is to be commensurate with the risks posed to study participants and with the size and complexity of the study. In addition, the OPD requires that a Grantee and any third party engaged in supporting the clinical research be responsible for oversight of data and safety monitoring, ensuring that monitoring systems are in place, that the quality of the monitoring activity is appropriate, and that the OPD Project Officer is informed of recommendations emanating from monitoring activities.
3.A.1. FDA Requirements for MonitoringThe specific approach to monitoring will depend on features of the clinical trial to be conducted e.g., several levels of monitoring: Data and Safety Monitoring Board (DSMB), Study Monitoring Committee (SMC) and Independent Medical Monitor (IMM). Monitoring activities should be appropriate to the study, study phase, population, research environment, and degree of risk involved. Guidance is available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf.
In small, single-site studies, safety monitoring is often performed by the independent medical monitor or a safety monitoring committee in conjunction with the study statistician. Phase 3 studies and high risk Phase 1 or 2 clinical trials frequently use a DSMB. It may be desirable to utilize a DSMB for:
A preliminary monitoring plan must be submitted as part of the Research Plan portion of the grant application for a clinical trial. The plan will be examined as part of the peer review process, and any comments and concerns will be included in an administrative note in the summary statement. OPD staff will ensure that all concerns are resolved before the grant award is made.
3.B. Oversight ActivitiesIn addition to the requirement for an active IND/IDE discussed in Section V.3 of this document, documentation of assurances with the Office of Human Research Protection (OHRP) (see Section IV.5.A of this document) must be on file with the FDA grants management office before an award is made. Any institution receiving Federal funds must have an institutional review board (IRB) of record even if that institution is overseeing research conducted at other performance sites. To avoid funding studies that may not receive or may experience a delay in receiving IRB approval, documentation of IRB approval and Federal Wide Assurance (FWA or assurance) for the IRB of record for all performance sites must be on file with the FDA grants management office before an award to fund the study will be made. In addition, if a grant is awarded, grantees will be informed of any additional documentation that should be submitted to FDA's IRB.
3.C. Reporting RequirementWhen multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement, dated January 1, 2007 (http://www.hhs.gov/grantsnet/adminis/gpd/). Also, all new and continuing grants must comply with all regulatory requirements necessary to keep the status of their IND/IDE active and in effect, that is, not on clinical hold. Failure to meet regulatory requirements will be grounds for suspension or termination of the grant.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
A listing and a justification for any study changes that occurred in the past year must be included in the Non-Competing Continuation Grant Progress Report (PHS 2590).
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: firstname.lastname@example.com
(Questions regarding application instructions and process, finding grant resources)
Telephone 301-710-0267
Email: firstname.lastname@example.com
Commons Help Desk (Questions regarding eRA Commons registration, tracking
application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Email: firstname.lastname@example.com
Grants Management Specialist
Division of Acquisition Support and Grants
Office of Acquisitions & Grant Services
5630 Fishers Lane, Room 1079
Rockville, Maryland 20857
Phone: 301-827-7177
E-mail: email@example.com
2. Scientific/Research Contact(s):
Director, Orphan Products Grants Program
Office of Orphan Products Development
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone: 301-796-8660
E-mail: email@example.com
3. Financial/Grants Management
Grants Management Specialist
Division of Acquisition Support and Grants
Office of Acquisitions & Grant Services
5630 Fishers Lane, Room 1079
Rockville, Maryland 20857
Phone: 301-827-7177
E-mail: email@example.com
Section VIII. Other Information
1.A. Clinical Trials Data Bank
The Food and Drug Administration Amendments Act of 2007 (FDAAA) contains
provisions that expand the current database known as ClinicalTrials.gov to
include additional requirements for individuals and entities, including
grantees, who are involved in conducting clinical trials that involve products
regulated by FDA or that are funded by the Department of Health and Human
Services (HHS), including FDA. These additional requirements include
mandatory registration of certain types of clinical trials, as well as
reporting of results for certain trials for inclusion in the ClinicalTrials.gov
database. ClinicalTrials.gov, which was created after the Food and Drug
Administration Modernization Act of 1997, provides patients, family members,
healthcare providers, researchers, and members of the public easy access to
information on clinical trials for a wide range of diseases and conditions. The
U.S. National Library of Medicine (NLM) has developed this site in
collaboration with NIH and FDA. ClinicalTrials.gov is available to the public
through the Internet at http://clinicaltrials.gov.
ClinicalTrials.gov contains information about certain clinical trials, both federally and privately funded, of drugs (including biological products) and medical devices. The types of trials that are required to be registered, and for which results must be reported, are known as "applicable clinical trials." FDAAA defines the types of clinical trials that are "applicable clinical trials" and, therefore, are subject to the registration and results reporting requirements. The registry listing for each trial includes information such as descriptive information about the trial, patient eligibility criteria, recruitment status, location information on the clinical trial sites, and points of contact for those wanting to enroll in the trial. The database also contains information on the results of clinical trials. More detailed information on the definition of "applicable clinical trial" and the registry and results reporting requirements can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html and http://prsinfo.clinicaltrials.gov/fdaaa.html.
FDAAA also added new requirements concerning clinical trials supported by grants from HHS, including FDA. Under these provisions, any grant or progress report forms required under a grant from any part of HHS, including FDA, must include a certification that the person responsible for entering information into ClinicalTrials.gov (the "responsible party") has submitted all required information to the database. There are also provisions regarding when agencies within HHS, including FDA, are required to verify compliance with the database requirements before releasing funding to grantees. OPD program staff will be providing additional information on these requirements, including the appropriate means by which to certify that a grantee has complied with the database requirements.
1.B. Data and Safety Monitoring
Section VI.3.A. for more detail and other FDA monitoring requirements.
The establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risk
to the participants, and generally for Phase 3 clinical trials. Although Phase 1
and Phase 2 clinical trials may also use DSMBs, smaller clinical trials may not
require this oversight format, and alternative monitoring plans may be
1.C. Access to Research Data
through the Freedom of Information Act (FOIA)
The Freedom of Information Act (FOIA), 5 U.S.C. 552, provides individuals with
a right to access certain records in the possession of the Federal government,
subject to certain exemptions. The government may withhold information pursuant
to the exemptions and exclusions contained in the FOIA. The exact language of
the exemptions can be found in the FOIA. Additional guidance on the exemptions
and how they apply to certain documents can be found in the HHS regulations
implementing the FOIA (45 CFR part 5) and FDA regulations implementing the
FOIA (21 CFR part 20). (Also see the HHS Web site http://www.hhs.gov/foia/ and FDA Web site at http://www.fda.gov/RegulatoryInformation/FOI/default.htm )
Data included in the application may be considered trade secret or confidential commercial information within the meaning of relevant statutes and implementing regulations. FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law.
1.D. Use of Animals in Research
Recipients of PHS support for activities involving live vertebrate animals must
comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=3&tax_subject=182&topic_id=1118&level3_id=6735&level4_id=0&level5_id=0&placement_default=0)
as applicable.
1. E. Inclusion of Women And
Minorities in Clinical Research
Applicants for PHS clinical research grants are encouraged to include
minorities and women in study populations so research findings can be of benefit
to all people at risk of the disease or condition under study. It is
recommended that applicants place special emphasis on including minorities and
women in studies of diseases, disorders, and conditions that disproportionately
affect them. This policy applies to research subjects of all ages. If women or
minorities are excluded or poorly represented in clinical research, the
applicant should provide a clear and compelling rationale that shows inclusion
is inappropriate.
1.F. Inclusion of Children as Participants
in Clinical Research
FDA regulations at 21 CFR part 50, subpart D contain additional requirements
that must be met by IRBs reviewing clinical investigations regulated by FDA and
involving children as subjects. FDA is part of HHS; accordingly, the research
project grants under this program are supported by HHS, and HHS regulations at
45 CFR part 46, subpart D also apply to research involving children as
1.G. Standards for Privacy of
Individually Identifiable Health Information
HHS issued final modification to the Standards for Privacy of Individually
Identifiable Health Information, the Privacy Rule, on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Web site http://www.hhs.gov/ocr/ provides information on the Privacy Rule.
1.H. Healthy People 2020
PHS is committed to achieving the health promotion and disease prevention
objectives of Healthy People 2020, a PHS-led national activity for setting
priority areas. This Funding Opportunity Announcement is related to one or more
of the priority areas. Potential applicants may obtain a copy of Healthy People 2020.
1.I. Smoke-Free Workplace
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
1.J. Authority and Regulation
This program is not subject to the intergovernmental review requirements of
Executive Order 12372. FDA's research program is
described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103 http://www.cfda.gov/.
FDA will support the clinical studies covered by this notice under the authority of section 301 of the PHS Act as amended (42 U.S.C. 241) and under applicable regulations at 42 CFR Part 52 and 45 CFR Parts 74 and 92. All grant awards are subject to applicable requirements for clinical investigations imposed by sections 505, 512, and 515 of the act (21 U.S.C. 355, or 360e) or safety, purity, and potency for licensing under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262), section 351 of the PHS Act, including regulations issued under any of these sections.
All human subject research regulated by FDA is also subject to FDA's regulations regarding the protection of human subjects (21 CFR Parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and Good Clinical Practice available on the Internet at http://www.fda.gov/oc/gcp/.
The applicant is referred to HHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details regarding the required elements of informed consent.
All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
| ||||||
Department of Health and Human Services (HHS) |
NIH... Turning Discovery Into Health® Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |


text:
Puerto Vallarta is a city and popular vacation resort on the Pacific Coast of Mexico.
Around the Bay, beautiful beaches, lush jungles, and sparkling waterfalls offer many opportunities for the adventurous, while five star resorts, world-class shopping, and gourmet restaurants satisfy even the most sophisticated traveler. Stretching from the south end of Old Town to central downtown, a newly extended and refurbished boardwalk along the ocean, called the Malecon, passes by any number of shops, restaurants, and hotels, and often plays host to mimes, breakdancers, clowns and artists. The residents of Puerto Vallarta are very friendly and generally willing to help with directions and other requests. Old TownVallarta (or the Zona Romantica district) south of the River Cuale is more like a Mexican town and less like a tourist trap. English is widely spoken, and as a tourist destination prices are higher than many other places in Mexico. Puerto Vallarta is very crowded at holiday times, if planning a visit to Mexico that coincides with a major holiday consider opting to visit Mexico City or Guadalajara instead. The cities empty out as Mexicans and tourists alike flood to the beaches.
Your book will be sent in PDF format readable on any device.
Edna Carroll · Email us · Phone: 5194680129

subset: commoncrawl


text:
- Story by Toby Tannas Photography by Lia Crowe
There isn't much down time when you're a busy obstetrician/gynecologist in a small but growing community. When Dr. Nicholas Half does have a moment to glance out his corner office window at the picturesque view of Vernon, he can't help but be grateful.
Over the past decade, Nicholas has built a beautiful life and practice in the North Okanagan city, but as a young med student this was not the vision he had for his career.
"Not a lot of men have the life dream of being a gynecologist," he chuckles. "Cardiothoracic surgery was my number one choice; orthopaedic surgery was my second choice, and at the top of the list of things I said I wouldn't consider was obstetrics/gynecology."
In his third year of medical school, when students started seeing patients on rotation in the hospital, Nicholas quickly ruled out his top two choices for various reasons and kept coming back to obstetrics/gynecology.
"It was just one of those things. It's got the medicine component, it's got patient care, it's a lot of conversation, not all surgery."
Ultimately though, it was the patients who cemented his medical future.
"I love what I do. Women are very communicative. They show gratitude and thankfulness. There's not a lot of specialties in medicine anymore where you hear 'thank you.' I hear those words every day."
Nicholas' love for the work and his commitment to his patients has recently taken him into a new realm of service: a user-pay procedure that's rarely offered in a gynecology clinic.
"It's called the MonaLisa Touch. It's a non-surgical laser treatment for vaginal dryness, discomfort and irritation."
After seeing many women suffer through sexual issues post menopause or after battling diseases like cancer, Nicholas decided to make a significant investment in an option that could improve their quality of life.
"You see cancer patients — they can't even touch estrogen and they suffer. These are women in their 30s and 40s and their sex life is gone. This is who this machine is for."
Regardless of why a patient is referred to his gynecology clinic, sexual health often comes up in conversation. Nicholas believes that when you can do something to improve or make sex more comfortable for a woman, her life and her relationship improve.
"Sex makes up about five per cent of the relationship when it's good," he explains. "But when it's not, or it's absent, it makes up 95 per cent of the relationship."
As a male in a field that's shifting to predominantly female care providers, Nicholas takes pride in the rapport he's developed with his patients.
"I think as a doctor you want to be someone a patient can talk to comfortably about whatever they want to talk about, and that feel they're being respected and listened to."
Nicholas is well practiced in communicating with women as he's married with three young daughters.
"We have twins. They're five years old and we have a three year old. So basically, we have triplets. It's busy," he laughs.
With more than 100 hours dedicated to work in an average week, Nicholas doesn't get to spend as much time with his kids as other dads with 9-to-5 jobs.
"My work life and home life balance could always be better; we all struggle with that as physicians. I just try to give them quality time. They just want to be with you, it doesn't matter if we're playing a game or building a gate."
Nicholas' wife, Dr. Aisha Manji, is also a physician. It means she understands first-hand the demands of the job.
Nicholas says, "I think that's probably the best thing, that understanding. I think even in a small community where you're hoping to have a better lifestyle than the big city, there are still a lot of demands in terms of what you can't miss, what you have to go to battle for, for your patients."
The couple will be getting some extra time together over the coming months, though. They've committed to dancing in support of the North Okanagan Hospice Society.
"My wife has a tie to the palliative community, end of life care. It's always been one of her passions."
Dancing with the Vernon Stars takes place this September. Between now and then, dance practices will become date nights.
"For us to spend that extra time together, dancing together will be nice," he says with a smile.
The dancing commitment is another weekly appointment in an already very full calendar. But as I sit across from Dr. Half, I get the distinct sense he's the kind of man who can juggle it all and do it well. Family man, physician, and for the next few months, fundraiser and dancer in support of a cause and a community very close to his heart.
"I love Vernon. My quality of life is great, I've got great people around me. That's what it's all about."


text:
Excerpt from The Black Count
Read now from the remarkable true story of the real Count of Monte Cristo
Below, read the first chapter of the remarkable true story of the real Count of Monte Cristo – a stunning, Pulitzer-Prize-winning feat of historical sleuthing that brings to life the forgotten hero who inspired such classics as The Count of Monte Cristo and The Three Musketeers.
the sugar factory
Alexandre Antoine Davy de la Pailleterie—father of the future Alex Dumas—was born on February 26, 1714, in the Norman province of Caux, a region of rolling dairy farms that hung above great chalk cliffs on the northwest coast of France. A scrawled scrap of paper from the time states that he was baptized "without ceremony, at home, because of the peril of death," suggesting he was too sickly to risk bringing in to the local church. He was the firstborn son of an old family that possessed a castle, a scarcity of cash, and an abundance of conniving members, though Antoine would one day outdo them all.
The boy survived, but the following year his sovereign, King Louis XIV, the Sun King, died after seventy-two years on the throne. As he lay dying, the old king counseled his heir, his five-year-old great-grandson: "I loved war too much, do not imitate me in this, nor in my excessive spending habits." The five-year-old presumably nodded earnestly. His reign, as Louis XV, would be marked by a cycle of spending and wars so extravagantly wasteful and unproductive that they would bring shame not only on his person but on the institution of the French monarchy itself.
But the profligate, war-driven habits of its kings could not hold France back. In fact the "Great Nation" was about to unleash the age of the philosophes, the Enlightenment, and all that would follow from it. Frenchmen were about to shake the world into the modern age. Before they could do that, they would need money. Big money.
Big money was not to be found in Normandy, and certainly not around the Pailleterie château. The family's coat of arms—three golden eagles holding a golden ring on an azure background—looked impressive but meant little. The Davy de la Pailleteries were provincial aristocrats from a region more abounding in old glories than in current accounts. Their fortune was not enough to sustain grandeur without work—or not for more than one generation.
Still, a title was a title, and as the oldest son, Antoine would eventually claim the title of "marquis" and the ancestral estate of Bielleville that went with it. Next in succession after Antoine were his two younger brothers—Charles Anne Edouard (Charles), born in 1716, and Louis François Thérèse (Louis), born in 1718.
Faced with their limited prospects in Normandy, all three Pailleterie brothers sought their fortunes in the army, which then accepted nobles as young as twelve into its commissioned ranks. Antoine received a commission in the Corps Royal de l'Artillerie, an up-and-coming branch of the service, as a second lieutenant at sixteen. His brothers soon followed him as teenage junior officers. The Pailleterie brothers were kept busy by His Majesty's plunge, in 1734, into the War of the Polish Succession, one of a series of dynastic conflicts that regularly provided excuses for the gory quaintness of eighteenth-century European combat. The big-power rivals behind this little war were the traditional competitors for European land domination, the Bourbons and the Hapsburgs, France and Austria. (England would soon play a bigger role, especially on the high seas and in the New World, but that was still one or two wars in the future.)
In addition to his commission in the artillery, Antoine served at the front as gentleman in the entourage of the Prince de Conti, the king's dashing, fabulously rich cousin. Antoine saw his main action at the Siege of Philipsburg, in 1734—later written into the military annals by Karl von Clausewitz, in On War, as the "perfect example of how not to site a fortress. Its location was that of an idiot standing with his nose against the wall." Voltaire was also there, fleeing a royal arrest warrant, and working as a kind of one-man eighteenth-century USO show during the siege, offering bons mots and brandy between bouts of battle and composing odes to the military men.
The most notable event in Antoine's service at Philipsburg, however, was that he served as a witness to a duel that took place on the night of the Prince de Conti's birthday party at the front: it was between the Prince de Lixen and the Duke de Richelieu. The duke took offense when the prince mocked the Richelieu pedigree. The duke's grandfather had been Cardinal Richelieu (later immortalized as the mustache-twirling nemesis of the Three Musketeers), an adviser to Louis XIII who had managed royal financial and building projects to great advantage—both for himself and for France. But such accomplishments did not measure up to the high standards of snobbery practiced by Lixen, who regarded the Richelieu clan as parvenus. To make matters worse, the duke had recently offended the prince by marrying one of his cousins.
At midnight, the illustrious in-laws met in the field of honor between the dining tents and the trenches. They began lunging at one another there in the dark, their lackeys lighting the swordfight with flickering lanterns. The prince took the advantage first, wounding Richelieu in the thigh. The lackeys switched from lanterns to bare torches, and the combatants chased each other in and out of the trenches, their blades reflecting fire. The prince stabbed the duke in the shoulder. At this point an enemy barrage lit the field of honor. One of the lackeys was hit and killed.
Richelieu counterattacked, and with Antoine watching, the duke sank his blade into the chest of his unfortunate in-law. Contemporaries considered it a sort of poetic justice, since Lixen himself had recently dispatched one of his own relations, his wife's uncle, the Marquis de Ligneville, for a similarly trifling offense. Such were the friendly-fire deaths of the eighteenth-century battlefield.
In 1738, when the war ended, Antoine took the chance to get out of the army and Europe altogether. While he was stationed at Philipsburg, his younger brother Charles had joined a colonial regiment that went to the French sugar colony of Saint-Domingue, on the West Indian island of Hispaniola. This was a fortunate posting.
Sugar planting was the oil business of the eighteenth century, and Saint-Domingue was the Ancien Régime's Wild West frontier, where sons of impoverished noble families could strike it rich. Barely sixteen when he arrived in the colony as a soldier, by twenty-two Charles Davy de la Pailleterie had met and wooed a young woman, Marie-Anne Tuffé, whose family owned a sizable sugar plantation on the colony's wealthy northeast coast. Antoine decided to join him.
Today, the world is so awash in sugar—it is such a staple of the modern diet, associated with all that is cheap and unhealthy—that it's hard to believe things were once exactly the opposite. The West Indies were colonized in a world where sugar was seen as a scarce, luxurious, and profoundly health-giving substance.
Eighteenth-century doctors prescribed sugar pills for nearly everything: heart problems, headache, consumption, labor pains, insanity, old age, and blindness. Hence, the French expression "like an apothecary without sugar" meant someone in an utterly hopeless situation. Saint-Domingue was the world's biggest pharmaceutical factory, producing the Enlightenment wonder drug.
Columbus brought sugarcane to Hispaniola, the first European settlement in the New World, on his second voyage, in 1493. The Spanish and the Portuguese had been the first to cultivate sugar in Europe, and when they began their age of discovery, among the first places they "discovered" were islands off the coast of North Africa just perfect for sugar cultivation. As the Iberian explorers made their way down the African coast—the Portuguese going around the Horn to East Asia, the Spaniards cutting west to the Americas—both powers had two main goals in mind: finding precious metals and planting sugarcane. (Oh, and spreading the word of God.)
The Spanish established a colony on the eastern side of Hispaniola and named it Santo Domingo; eventually, the colony would extend over the eastern two-thirds of the island, roughly corresponding to the modern-day Dominican Republic. (The native inhabitants called the entire island by another name: Hayti.) The Spanish brought artisans from the Canary Islands, off the coast of West Africa, to build the elaborate on-site technology needed for sugar production—presses, boilers, mills—and then brought the most essential ingredient of all: African slaves.
Slavery, of course, had existed since antiquity. The Greek city-states had created democracy among a small elite by enslaving almost everybody else, in some cases up to a third of the population. Aristotle believed democracy could exist only because of slavery, which gave citizens the leisure for higher pursuits. (Modern versions of this argument held that American democracy was born of the slave society of rural Virginia, because slavery gave men like Washington and Jefferson the free time to better themselves and to participate in representative government.) In Greece and Rome, slavery was the fate of prisoners of war and barbarians, anyone not lucky enough to have been born Greek or Roman. When ancient slaves managed to buy their freedom or that of their children, they would assimilate into the free population, with no permanent mark on their descendants. Though ubiquitous in the ancient world, slavery was not based on any sense of "race."
There was an ethnic connotation in the etymology of the word "slave," which first appeared in the eighth century AD: the word was a corruption of "Slav," since at the time nearly all slaves imported into Europe were ethnic Slavs. The Slavs were late converts to Christianity, and their pagan status made them vulnerable. "Slav markets" were established across Europe, from Dublin to Marseilles, where the people being bought and sold were as fair-skinned as those buying and selling them.
The rise of Islam led to a vast expansion of slavery, as conquering Arab armies pulled any and every group of "unbelievers" into bondage. Arab slave traders captured whites from the north via sea raids on European shipping, and blacks from the south via land raids or barter with the sub-Saharan kingdoms. Justified by religious faith, the Muslim slave trade was a huge trans-national business. Over time it focused more and more on black Africans. Yet there was still no fixed biological marker for bondage.
The European sugar trade changed this forever. As thousands of blacks were bought and sold out of Africa to harvest sugar, for the first time in history a biologically marked group of human beings came to be considered destined for slavery, created by the white landowners' God for a life of permanent chattel servitude.
The Portuguese had first taken blacks to Madeira to cut sugarcane because the island was off the coast of North Africa and the Muslim traders there happened to deal in African slaves. When they sailed down the Guinea Coast, the Portuguese found the black African kingdoms were willing to supply them with slaves directly: the Africans did not consider they were selling their racial brothers to the whites. They did not think in racial terms at all but only of different tribes and kingdoms. Before, they had sold their captives to other black Africans or to Arabs. Now they sold them to whites. (The African kingdoms and empires themselves kept millions of slaves.) As time went on, Africans would learn of the horrors awaiting black slaves in the American colonies, not to mention on the passage over, yet they continued to export ever greater quantities of bois d'ébène—"ebony wood," as the French called their cargo. There was no mercy or morality involved. It was strictly business.
Spain laid the foundations of this great wealth and evil in the Americas, then quickly became distracted and forgot about it. After introducing the plants, the technology, and the slaves into Santo Domingo, the Spanish dropped the sugar business in favor of hunting for gold and silver. They moved on to Mexico and South America in search of the precious metals, leaving the island to languish for nearly two centuries, until the French began to harness its true potential.
By the mid-to-late eighteenth century, the Saint-Domingue colony, situated on the western end of Hispaniola, where Haiti is today, accounted for two-thirds of France's overseas trade. It was the world's largest sugar exporter and produced more of the valuable white powder than all the British West Indian colonies combined. Thousands of ships sailed in and out of Port-au-Prince and Cap Français, bound for Nantes, Bordeaux, and New York. When the British, after winning the Seven Years' War, chose to keep the great swath of France's North American colonies and instead return its two small sugar islands, Guadeloupe and Martinique, they unwittingly did their archrival a favor.
Saint-Domingue was the most valuable colony in the world. And its staggering wealth was supported by staggering brutality. The "pearl of the West Indies" was a vast infernal factory where slaves regularly worked from sunup to past sundown in conditions rivaling the concentration camps and gulags of the twentieth century. One-third of all French slaves died after only a few years on the plantation. Violence and terror maintained order. The punishment for working too slowly or stealing a piece of sugar or sip of rum, not to mention for trying to escape, was limited only by the overseer's imagination. Gothic sadism became commonplace in the atmosphere of tropical mechanization: overseers interrupted whippings to pour burning wax—or boiling sugar or hot ashes and salt—onto the arms and shoulders and heads of recalcitrant workers. The cheapness of slave life brushed against the exorbitant value of the crop they produced. Even as the armies of slaves were underfed and dying from hunger, some were forced to wear bizarre tin-plate masks, in hundred-degree heat, to keep them from gaining the slightest nourishment from chewing the cane.
The sugar planter counted on an average of ten to fifteen years' work from a slave before he was driven to death, to be replaced by another fresh off the boat. Along with malnutrition, bugs and diseases could also eventually do in someone working up to eighteen hours a day. The brutality of the American Cotton Kingdom a century later could not compare to that of Saint-Domingue in the 1700s. There would be no shortage of cruel overseers in the United States, but North American slavery was not based on a business model of systematically working slaves to death in order to replace them with newly bought captives. The French sugar plantations were a charnel house.
Because Versailles loved laws and orders, France was the first country to codify colonial slavery. In doing so, King Louis XIV passed a law, in 1685, that changed the history of both slavery and race relations.
Le Code Noir—the Black Code. Its very name left no doubt about who were to be the slaves. It elaborated, point by point, the many ways in which black Africans could be exploited by their white masters. The Code sanctioned the harshest punishments—the penalty for theft or attempted escape was death—and stated that slaves could not marry without their master's consent or pass on property to their kin.
But the very existence of a written legal code—a novelty of the French colonial empire—opened the way for unexpected developments. If there were laws governing slavery, then slave owners, at least in some instances, could be found in violation of them. By articulating the rules of white domination, the Code, theoretically, at least, limited it, and gave blacks various opportunities to escape from it. It created loopholes. One of these was on the issue of sexual relations between masters and slaves, and the offspring resulting from such relations.
Related Posts:


text:
Is this the first sign of trouble for the Facebook IPO?
The social media giant, now in the final weeks before its long awaited IPO filing, announced Monday that first-quarter profit and revenue has slipped since the end of 2011.
Facebook (Nasdaq: FB) disclosed in a regulatory filing that profit fell 32% from the previous quarter to $205 million. Revenue dropped 6% to $1.06 billion. Sales were up 45% -- slower than the 55% sales growth in the last quarter.
Expenses surged on costs related to data center building and workforce growth as the company manages its increasing subscriber base that's climbed to 901 million users worldwide. Expenses soared to $677 million - nearly double what they were a year ago.
Facebook also blamed the drop on "seasonal trends" in advertising and user growth in regions that bring in less revenue per subscriber.
"Our costs are growing quickly, which could harm our business and profitability," the company said in the filing. "Providing our products to our users is costly and we expect our expenses to continue to increase in the future as we broaden our user base, as users increase the number of connections and amount of data they share with us, as we develop and implement new product features that require more computing infrastructure, and as we hire additional employees."
Will Investors Back Off Facebook?
The profit and revenue slide has triggered concern about Facebook's forecasted earnings.
"Facebook has a pretty steep hill to climb to meet the expectations that we set out," Debra Aho Williamson of EMarketer Inc. told Bloomberg News.
EMarketer projected 2012 sales of $6.1 billion.
"It was a faster slowdown than we would have guessed," Brian Wieser, an analyst with Pivotal Research Group, told Reuters. "No matter how you slice it, for a company that is perceived as growing so rapidly, to slow so much on whatever basis - sequentially or annually - it will be somewhat concerning to investors if faced with a lofty valuation."
The data shows that Facebook's post-IPO days won't match its previous meteoric rise in popularity. Investors who bank on the same rate of growth will be disappointed-and could change their attitudes toward the Facebook IPO.
"The biggest issue is the realization that Facebook is not going to have an easy time meeting high expectations of the public market," Jeff Sica, chief investment officer of SICA Wealth Management, told Reuters. "It will affect how people look at the IPO. I'm still encouraging people to participate in the IPO, under the acknowledgement that it could be a bumpy ride. There are high expectations and I hate high expectations."
Facebook to Market in May
Recent rumors have slated May 17 as the Facebook IPO date.
Facebook will make a grand entrance with a value around $100 billion. It seeks to raise $10 billion at a $100 billion valuation, give or take a few billion dollars.
The actual timing of the IPO depends on how quickly the U.S. Securities and Exchange Commission completes reviewing the initial public offering paperwork, which just became more involved following Facebook's recent acquisition of Instagram.
Besides the $1 billion Instagram deal announced April 9, Facebook just agreed to pay Microsoft Corp. (NASDAQ: MSFT) $550 million for patents that the software company just purchased from AOL.
AOL announced April 9 it sold more than 800 patents and related applications to Microsoft for $1 billion at an auction, and gave Microsoft a non-exclusive license to the patents it retains.
AOL's patent portfolio includes fundamental social-networking patents, highly coveted in the tech world.
Had a Facebook "enemy" - such as Yahoo! Inc. (NASDAQ: YHOO) - gotten hold of the property, CEO Mark Zuckerberg and friends could have been hit with more lawsuits. Yahoo already has launched an all-out patent assault on Facebook.
The AOL deal also kept the patents away from Google Inc. (Nasdaq: GOOG), which has been trying to build up its Google+ social networking site.
"Besides the two deal partners and shareholders, Facebook is the number-one beneficiary," Florian Mueller, an independent intellectual property analyst and consultant, told CNNMoney. "An independent AOL or any other buyer would have picked Facebook as the first target, but Microsoft is a friend. Google once again missed out on a unique opportunity."
News and Related Story Links:
- Money Morning:
Facebook IPO: Where's the Love, Mark Zuckerberg?
- Money Morning:
Buy, Sell or Hold: When to Buy Shares of Facebook
- The Wall Street Journal:
Facebook's Growth Slows as IPO Nears
- CNNMoney:
AOL surges 42% on $1 billion patent deal